VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1507979
Sex: F
Age:
State: AR

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity; sore throat with discomfort; sore throat with discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:15 (at the age of 28-year-old) as single dose for covid-19 immunisation. COVID-19 vaccine was administered at Public Health Clinic/Administration facility. Medical history included drug hypersensitivity to penicillin, amoxicillin. Concomitant medications included ethinylestradiol, norgestimate (TRI-LO-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, the patient experienced elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity, sore throat with discomfort. The patient underwent lab tests and procedures which included heart rate: elevated in the range of 90-170 on 18Mar2021, normal range of inactivity 65-75. No treatment was given for the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: TRI-LO-SPRINTEC

Current Illness:

ID: 1507980
Sex: F
Age:
State: CA

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: it felt like it wiped out all her medicines and made her feel like she had no ilaris in her; the entire body and joints were hurting; the entire body and joints were hurting; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Reference ID: NVSC2021US040953_OS). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Mar2021 (Age at vaccination 64-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she had COVID vaccine yesterday and it felt like it wiped out all her medicines and made her feel like she had no ilaris in her. This occurred 5 hours after vaccine. Husband is an HCP who administered the vaccine, and the entire body and joints were hurting. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1507981
Sex: M
Age:
State: TX

Vax Date: 03/16/2021
Onset Date: 03/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Headache; Fever; Stomachache; General malaise; Oxygen saturation decreased/ oxygen level was 96 then went down to 95, then 94, and then 93; feels real weak; This is a spontaneous report from a contactable consumers. A 65-year-old male patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm (at the age of 65-year-old) on 16Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart surgery from Apr2020 to an unknown date, hypertension from Apr2020 to an unknown date, Autonomic dysfunction from 1989 to an unknown date and COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient did not had any other recent vaccinations or not started any new medications. The patient previously received first dose of bnt162b2, (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via unspecified route of administration (at the age of 65-year-old) on 23Feb2021 as single dose for COVID-19 immunisation. The patient experienced headache, fever, stomachache, general malaise, oxygen saturation decreased and feels real weak on Mar2021. The second dose was given yesterday and this morning he is having adverse reactions, and she would like to know what they can do to help him. She says he had a high fever, a stomachache, and a headache. She says his oxygen level was 96 then went down to 95, then 94, and then 93 on Mar2021. Patient says that his headache, fever, and stomachache are getting a bit better, but he had general malaise and feels real weak. He says he feels very bad like when he had COVID-19 this past Jan2021. He says that it was diagnosed with a deep swab, not the shallow one, in both nostrils and was a 24 hour test that was positive, it was not a rapid test. He says he had recovered from COVID-19. The patient underwent lab tests and procedures which included oxygen saturation: 95, oxygen saturation: 94, oxygen saturation: 96, oxygen saturation: 93 on Mar2021 and sars-cov-2 test: positive on Jan2021. The outcome of the events headache, fever, and stomachache was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1507982
Sex: U
Age:
State: TX

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 17Mar2021 10:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 1 via an unspecified route of administration on 24Feb2021 as a single dose for covid-19 immunization. On 17Mar2021, the patient experienced "about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll it's about happening and it's big rod and this knot came up from the injection site and it's real hot and its real hard and its real red". Outcome of the event was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1507983
Sex: M
Age:
State: AZ

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Memory problems with me and my husband. Can not remember words and places normally not a problem; This is a spontaneous report from a contactable consumer (spouse). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 10Feb2021 12:00 PM on Arm Left as dose 1, single; and then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 13Mar2021 on Arm Left as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products was Codeine. No prior vaccination done. List of any other medications the patient received within 2 weeks of vaccination reported as yes. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient was been tested for COVID-19. On an unspecified date in Feb2021. the patient reported, Memory problems with her and her husband. Cannot remember words and places normally not a problem. They were not really concerned but curious if this is in fact due to the vaccines. It appears to have started happening shortly after first vaccine and continued to be worse after the second vaccine. No treatment received for the adverse event. The patient underwent lab tests and procedures which included covid-19 negative on 05Mar2021. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318689 similar report from same reporter

Other Meds:

Current Illness:

ID: 1507984
Sex: M
Age:
State: MN

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: headache; Little bit of cough; sinus discomfort; difficulty in breathing; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (Wife) reported that a 75-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left (Left shoulder) on 26Feb2021 (at the age of 75-year-old) (Lot Number: EN6205, NDC number, UPC number, Expiry Date: Unknown) as dose 1, single for covid-19 immunisation. Medical history included Blood pressure high, anxiety, High cholesterol, Thyroid issues, breaks out itching terrible, for his allergies, he was constipated from Jan2021 (He just couldn't get his bowel movement there are some arteries that run from stomach to small intestine and that were narrowing). Concomitant medication(s) included citalopram (40 mg, tablet, once a day) taken for anxiety; atorvastatin (40 mg, once a day, tablet) taken for High cholesterol; levothyroxine (112 mcg, once a day, tablet) taken for Thyroid issues; fexofenadine (180 mg, tablet, once a day as needed) taken for itching terrible and for his allergies; amlodipine (generic Norvasc, 10 mg, tablet, once a day) taken for high blood pressure; for all start and stop date were not reported. On an unspecified date, the patient experienced headache, little bit of cough, sinus discomfort, difficulty in breathing. Caller was calling to report some adverse events (headache, sinus, difficulty in breathing, cough) experienced by her husband. She mentioned that they got the 1st vaccine shot together on 26Feb2021 and are scheduled for 2nd shot tomorrow (19Mar2021). She wants to know if her husband can still get the vaccine tomorrow despite the adverse events. Additional Information for Concomitant Products Levothyroxine: Indication: Reporter stated, "Thyroid issues." Dates for Concomitant Products Fexofenadine: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Fexofenadine: Reporter stated, "Once in a while he just breaks out itching terrible, for his allergies, she guess." Reporter stated, " Reporter just had a question, my husband and Reporter just had first Pfizer Covid shot on 26Feb2021 and now they are due to have our second shot due for tomorrow but about last week her husband just had a headache, little bit of cough, some sinus discomfort, he was pretty blocked up, but he finally get up today feeling like he could breathe better, Reporter was just wondering since patient was having headache and all these other little symptoms, should patient have his second shot tomorrow". When paraphrased the concern reporter confirmed the same and stated, "Right, he had a sinus discomfort, he was little stuffed up, he has little bit of cough almost every day, anyway reporter didn't know if these symptoms were could have come from his last shot specially the headache or its just normal for him to like since he got headache and stuff anyway, he should go and have his second shot tomorrow because the papers that they gave us when he got his first shot the headache especially could be a side effect from and reporter was like he already got a headache that's her question that should we go and get his second shot anyway. Email address: Reporter stated, "They did not have an email, They did not have a computer. Reporter stated, "No, her husband was a Pharma and reporter was a homemaker." Facility of vaccination details: Email address: Reporter stated, "No, she don't have that." Expiration date, NDC# and UPC#, Reporter stated, "Reporter was not seeing it on the card they gave us at the clinic. Site of Administration of vaccine: Left shoulder. Other medications: Reporter stated, "He has some thyroid issues, he takes Synthroid (later clarified as Levothyroxine), for his high blood pressure, it was generic Norvasc, 10 mg, once a day, tablet (further not clarified). Diagnosis date of High Blood pressure, High Cholesterol and anxiety, reporter stated, "reporter could not because he was having issue for years and reporter could not remember when he was diagnosed with the stuff." Laboratory work: Reporter stated, "Yes, in Jan2021, he was not feeling good so we take him to the emergency room and they found out that he was constipated. He just couldn't get his bowel movement they saw and reporter could not tell you want kind it was, they saw and understand that he was constipated, there are some arteries that run from stomach to small intestine and that were narrowing, doctor said that when they are narrowing bowel don't work, so reporter did not know they did enemas and told him to take bunch of stuff and it took couple of weeks but we got him going again and he has seen a specialist, he has seen a doctor, did ultrasound and did some work studies of his abdomen and checked out that artery and that specialist didn't think it was bad enough, they put the stuff in, so that was last in January." Date of the test, reporter stated, " reporter did not think this all worth it, its 05Jan2021, we took him to the emergency he had complete blood count, comprehensive metabolic panel, 'CT' abdomen, ECG, chest X-ray." Still experiencing events: Reporter stated, "Headache was now about for a week now, his headache was little left, and when he got up he could breathe a little better, his sinus discomfort seems like every morning he got all stuffed up, he just coughed little bit in the morning, he just cleared out, but that was kind of normal for him but reporter was just wondering if some of those symptoms were from first shot and he should go for second shot." Treatment: Reporter stated, "No, he was showing Primary Physician for years for sinus and stuff." The outcome of events was recovering. Follow-up (31May2021): Follow-up attempts completed. No further information expected.

Other Meds: CITALOPRAM; ATORVASTATIN; LEVOTHYROXINE; FEXOFENADINE; AMLODIPINE

Current Illness:

ID: 1507985
Sex: F
Age:
State: MN

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: very exhausted after this vaccine; shortness of breath; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date not reported) via unspecified route of administration on 17Mar2021 (at age of 74-years-old) as dose 1, single for COVID-19 Immunisation. Medical history included stroke and blood thinner. Concomitant medications included apixaban (ELIQUIS) used for blood thinner. Consumer stated, had my vaccine on the 17Mar2021 and that day I was just very exhausted after this vaccine but then that night I had shortness of breath, a headache and nausea and that lasted for 5 days. Now today was the first day, the patient feel back to normal again after 5 days and was kind of afraid to get my second shot. Patient enquired was that it will okay or what are, will it just dissipate like the other one. The outcome of all events was recovered on 22Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ELIQUIS

Current Illness:

ID: 1507986
Sex: F
Age:
State: TX

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: that look like hives; red pimples and hives like thing; On her stomach; little red lumps over her body or belly/red pimples/On her stomach; It looks like shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via an unspecified route of administration on 15Mar2021 as dose 2, single for covid-19 immunization (vaccinated at 68 years of age). The patient medical history and concomitant medications were not reported. The patient experienced that look like hives; red pimples and hives like thing; on her stomach, little red lumps over her body or belly/red pimples/on her stomach, it looks like shingles on an unspecified date in Mar2021. Reporter's wife got the second dose on 15Mar2021. About 1 week later, she got hives on her stomach. Reporter asked if it was a side effect of the vaccine. Reporter stated, his wife and he, they got the second dose of Pfizer Covid vaccine last week and his wife yesterday started to break out it was not hives but they were little red lumps over her body or belly. She had gone to the doctor but the doctor didn't know, the doctor didn't have experience with Pfizer vaccine and what he want to find was, was that a side effect that had been reported. Reporter stated, it was just basically around the belly, around the thigh. It looks like shingles, but the doctor said it wasn't shingles, but he didn't know what it was. The Pfizer thing was new, and the side effect was new so he don't know. Reporter stated, he doesn't know what her body weight was. Reporter stated, the doctor gave her some cream to put on the red spots, the things have popped up. Therapeutic measures were taken as a result of events which includes cream. The outcome for all events was unknown. No follow-up attempts are needed, Information on lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1507987
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Slight nausea, headaches; Slight nausea, headaches; my arm hurting but the shortness of breath bothered; my arm hurting but the shortness of breath bothered; fatigue; This is a spontaneous report received from a Pfizer Pfizer from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2, solution for injection; batch/lot number not reported), via an unspecified route of administration, on an unspecified date, as Dose 1, single for COVID-19 immunization. Medical history included melanoma. The patient's concomitant medications were not reported. Phone call received from the patient and during the call, the patient stated, "I'm in excellent health. I went to get the first Pfizer vaccine'. On an unspecified date, she stated that she received first dose of vaccine 4 weeks ago and had a horrible reaction. she had everything, slight nausea, headaches which did not bother her, and she did not care about her arm hurting but the shortness of breath bothered her, and it was the fatigue that bothered her beyond anything I had ever experienced before. After 3 days, it took her two days to recover from the reaction. Now last week, she was supposed to get the 2nd shot and quite frankly she chickened out. So, she made the appointment for this week and she was supposed to go this afternoon. She asked, there was anything she could do to lessen the reaction and she was scared of this vaccine. She had Melanoma and stated that she has never had an experience like this. Caller stated that her primary provider informed her, she might have to get Johnson and Johnson vaccine for second dose. The outcome of all the events was resolved. Note: The patient's date of birth and patient's gender, were not provided during the call. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1507988
Sex: M
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Ball under armpit; Ball under armpit; This is a spontaneous report from a contactable consumer or other non-HCP (patient's girlfriend). A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in Arm Left on 15Mar2021 09:30 (age at the time of vaccination 19-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. No prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced Ball under armpit. Patient did not received treatment for adverse event. Caller wanted to see if it was swollen lymph nodes. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1507989
Sex: U
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: shortness of breath; I have been more pain than I was before I got the shot; arthritis on my leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ZL7PHD, Expiration date was not reported), via an unspecified route of administration, on 04Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included that patient have been more pain than was before patient got the shot and ongoing arthritis (Cortisone shot for arthritis). Concomitant medications was not reported. On an unspecified date, consumer stated, "I received my vaccine on 4th (04Mar2021) of this month and on the 8th (08Mar2021) I got a cortisone shot for my arthritis on my leg and I have been reached, I have been shortness of breath and also on my leg when I got the cortisone shot I called the doctor and told to call me back. I have been more pain than I was before I got the shot. So, consumer wanted to know is these side effects due to vaccine. Consumer stated, "It do not have no number. It is a number here ZL7PHD. Is that the number I do not have it and wanted to know that he could take 2nd shot on 25th. This was all I have, I do not know. I just want to know what the side effects is when I take the shot". Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Arthritis (Cortisone shot for Arthritis)

ID: 1507990
Sex: F
Age:
State: CA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Abdomen may be swollen; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534, expiry date: not reported) via an unspecified route of administration on 16Mar2021 (at the age of 59-years old) as dose 1,single for covid-19 immunisation. Medical history included Low thyroid, Restrictive lung disease. The patient was not taking any treatment for the condition reportedly. Concomitant medication included levothyroxine sodium (TIROSINT) taken for hypothyroidism. On an unspecified date, the patient experienced abdomen may be swollen. The patient had never felt this way before and it happened since the patient had the first dose. Therapeutic measures were taken as a result of the event with Advil, 200 mg. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: TIROSINT

Current Illness:

ID: 1507991
Sex: F
Age:
State: MS

Vax Date: 03/16/2021
Onset Date: 03/24/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: itch at injection site, became red, raised and swollen; pain; pinkish/red coloring around the injection site area; There's like a big lump; kind of light headed/dizzy; Felt kind of scared/Feels funny; itching/Right arm started to itch/itch at injection site; it started to swell and was red all around the injection site; This is a spontaneous report from a contactable consumer. A 75-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EP7534, Expiration date: Not provided), via an intramuscular route in the left arm on 16Mar2021 (Tuesday) at 13:00 (age at vaccination: 75-year-old), as a single dose for covid-19 immunization. Medical history included allergic to Wellbutrin and toxoplasmosis. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, yesterday around 18:00, patient was sitting on the couch experienced right arm started to itch/ itch at injection site. She had been outside and picked up a pot and she thought maybe she got bit by a fire ant or something, it wasn't where the needle went in it was to the right of the injection site. Patient thought she just kind of kept itching and didn't think too much about it. Then she was looking at it again and it started to swell and was red all around the injection site. On 25Mar2021, there's like a big lump. It was swollen yesterday evening too and red and patient put some Benadryl gel on it. States that didn't really help and it was itching and was dizzy. She has this chigger 2x the power for chigger tic and all bug bites, with 10% benzocaine in it, it says fast soothing relief with aloe Vera, states it is for chigger bites. Patient reports that really helped. This morning it was still itching again after she took her shower. She looked and the whole area on her left arm around the injection site was pink and swollen like she got a small size potato on her arm up there from the swelling. The swelling feels like its kind of hard, felt kind of scared. She put some more of the chigger product on it to stop the itch, chigger X power, 10X power. Now she has taken a Benadryl at 08:45 this morning, one capsule, says she just felt kind of lightheaded. On 27Mar2021 also patient left started to itch at injection site, became red, raised and swollen. Her primary care doctor recommended to take Tylenol for pain. Next morning, on 28Mar2021, she took one Benadryl, left arm injection site still, pink swollen and itched. Ice did not help but warm water helped at injection site was also dizzy, lighted headed on 28Mar2021. Her husband is highly allergic to fire ant bites, she always keeps Benadryl. She thought maybe that's what it was when she picked up the flowerpot. Maybe it was something. Patient says she doesn't know, she has never had anything like this happen before. She didn't think it was the fire ant. Patient wanted to know if this is going to lead to why she might be having a reaction 7 days later or is this part of the helping with research? She wants to know if she needs to have my husband take her to the hospital or was she going to be okay. States she feels funny. Patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EM6207), via an intramuscular route in the right arm on 06Apr2021 at 09:30, as a single dose for covid-19 immunization. The clinical outcome of the events was finally subsided about 4 days out 31Mar2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1507992
Sex: M
Age:
State: TN

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: golf ball sized lump at injection site; golf ball sized lump at the injection site. it is warm and tender to the touch.; golf ball sized lump at the injection site. it is warm and tender to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration on 17Mar2021 at 13:00 (at the age of 40-year-old), as a single dose for COVID-19 immunization. Medical history included diabetes, liver disorder and covid-19. Concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. It's unknown whether the patient had any allergies. On 17Mar2021, the patient experienced golf ball sized lump at the injection site, warm and tender to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The patient underwent lab test and procedure which included BMI with unknown result. The clinical outcome of the events vaccination site lump, vaccination site warmth and vaccination site tenderness were not resolved at the time of this report. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1507993
Sex: F
Age:
State: GA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: felt a 50 cent piece size hard lump on her head that hurts and is hard to the touch; Bad Headache; Legs felt Weak; Tiredness; This is a spontaneous report from a contactable consumer (Patient). A 82-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on 18Mar2021 at 13:30 (at the age of 82-year-old) into left arm as a single dose for COVID-19 immunization at doctors Office.The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6203), via an unspecified route of administration on 22Feb2021 (at the age of 81-year-old) in to Left arm as a single dose for COVID-19 immunization at doctor Office. The patient medical history included ongoing Asthma, COVID-19 from Dec2020 to an unknown date. Concomitant medication(s) included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing. The patient previously took flu shot every year and had no issues with it. On 18Mar2021, the patient experienced Tiredness. On 19Mar2021, the patient experienced Bad Headache and Legs felt Weak. On 21Mar2021, the patient felt a 50-cent piece size hard lump on her head that hurts and is hard to the touch. It was reported that she is calling about the Pfizer Vaccine; verified Pfizer Covid Vaccine. Patient stated that she had her second shot on Thursday 18Mar2021. She states that on Sunday, she was rubbing her head and she felt a 50-cent piece size hard lump on her head. She states that she called the doctor office yesterday and explained it to them and they got back to her today and they told her that they weren't aware of anything like that, it might be something that they didn't know. She states they said it may be another reaction that wasn't on the list. She states that they told her to call Pfizer to see if it has been reported. She states that she is calling to find out if that is a side effect and what she can do. She states that the lump hurts and is hard to the touch. She states that (Name withheld) is the one that gave her the shot and she got the first one there too. States that she has been going there for quite a few years. She states that he knows about this and is the one that told her to call Pfizer. On Thursday, she came home and went to bed at 10:00p.m. She states she remember thinking she can't wait until she flops in bed. She states that her daughter woke her up the next afternoon around 4:00p.m. She states that she felt like going back to sleep after she woke up in the afternoon and would dose off. She states it was gone by 20Mar2021.she also had a bad headache that started on 19Mar2021. She states that she took two Tylenol, and it was gone later that day on 19Mar2021.Her legs felt weak after she woke up in the afternoon on 19Mar2021. States it resolved by 20Mar2021.She had a mild case of COVID in December and she was in the hospital for 2 days. She states the doctor said to wait 3 months before getting the first dose. She also has a puffer in her pocketbook for emergency asthma attacks. The patient was not visited to emergency room and physician office for the events. The patient did not receive any vaccine Prior Vaccinations (within 4 weeks). The outcome of the events was recovered for Bad Headache on 19Mar2021, recovered for Tiredness and Legs felt Weak on 20Mar2021, not recovered for felt a 50 cent piece size hard lump on her head that hurts and is hard to the touch. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds: BREO ELLIPTA

Current Illness: Asthma (Verbatim: Asthma)

ID: 1507994
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/26/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: 9 days after the vaccine, the injection site swelling; Injection site redness; injection site warmth; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6207/EN6206, Expiry Date: Unknown) via an unspecified route of administration in left arm on 18Mar2021 at 19:30 (at the age of 30-year-old) as dose 1, single for COVID-19 vaccination. Medical history included asthma, COVID-19 and ADHD. Concomitant medications received within 2 weeks of vaccination included dexamfetamine saccharate, amfetamine sulfate, amfetamine aspartate (ADDERALL) for unknown indication on an unknown date, levocetirizine dihydrochloride (XYZAL) for unknown indication on an unknown date. Allergic to medications included CECLOR (MANUFACTURER UNKNOWN), BACTRIM (MANUFACTURER UNKNOWN) and AUGMENTIN (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00, 9 days after the vaccination, the injection site swelling surface area had increased from the size of a golf ball. It was still red and still warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of vaccination site swelling, vaccination site erythema, vaccination site warmth was not recovered. No follow up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's address added and Past drug event Augmentin was coded.

Other Meds: ADDERALL; XYZALL

Current Illness:

ID: 1507995
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: lightheadedness; shaking; This is a spontaneous report from non-contactable other healthcare professional. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: EN6205) via unspecified route of administration on 22Mar2021 (at the age of 35-years-old) as second dose, single for COVID-19 immunisation. Medical history included hypoglycemia from and unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: unknown) via unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 22Mar2021, during her fifteen minutes waiting period of injection, the patient began to experience light-headedness and shaking. The patient denied rash, difficulty breathing, difficulty swallowing, wheezing, itching and facial swelling. The patient complained of dizziness. Treatment included: water. The patient's follow up response towards treatment was good. The patient was escorted out of the facility and denied symptoms while ambulating out. The patient discharged and was stable to go home and follow up with primary care physician. Treatment was taken for the event which included with water. The clinical outcome of the light-headedness and shaking was resolved on 22Mar2021. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Block was updated from Block 17 to Block 13 and also Block 10 ticked for SD BNT162B2. Treatment included: water added in the narrative.

Other Meds:

Current Illness:

ID: 1507996
Sex: F
Age:
State: OH

Vax Date: 03/17/2021
Onset Date: 03/24/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1507997
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/26/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Digestive issue; Loose stool; Dehydration; Dizziness; weight lost; Head ache; Chills; Whole body ache; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Er2613 and expiration date was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 14:45 (at the age of 63-years-old) as a dose 1, single for COVID-19 immunisation. Medical history included unspecified immunity deficiency (bad immune system), the patient was allergic to dairy (milk allergy) and codeine. Other medications that the patient received within two weeks of vaccination included magnesium, vitamin b-12(MANUFACTURER, K2 with D3, vit C and better bitters. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021, the patient experienced headache, chills, whole body ache, digestive issue, loose stool, dehydration, dizziness and weight loss and it was day four only very slight improvement. The patient underwent lab test procedures weight and result was lost on 26Mar2021. The clinical outcome of indigestion, loose stools, dehydration, dizziness, weight loss, headache, chills and general body pain was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's "Age at Vaccination/Units" captured as "63 years" per vaccination date=22Mar2021 and DoB. 2. For History "allergies: Dairy": Coding updated from "Dairy intolerance" to "Milk allergy" per MedDRA. 3. For History "Bad immune system": Coding updated from "Unspecified immunity deficiency" to "Immune system disorder". 4. For "Past Drug Event": Reaction Coding updated from "Allergy" to "Drug allergy". 5. "weight" captured as Lab Data with Result "lost" and Test Date "26Mar2021". 6. No Drug Code for Con-Med "B-12" and "VIT C", coded out in Product tab. 7. Con-Med "K2 with D3" coded in tab as "D3 +K2". 8. For event "Digestive issue": Please review if need update the Coding from "Indigestion" to "Functional gastrointestinal disorder" per MedDRA. 9. Initial information need review: List of any other medications the patient received within 2 weeks of vaccination: Magnesium, B-12, K2 with D3, Vit C, Better Bitters

Other Meds: MAGNESIUM; B-12; VIT C; D3 +K2

Current Illness:

ID: 1507998
Sex: F
Age:
State:

Vax Date: 03/20/2021
Onset Date: 03/29/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: rashes on arm; itchiness on arm; This is a spontaneous report from a non-contactable consumer. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the arm on 20Mar2021 (at the age of 42-years-old), as asingle dose for COVID-19 immunisation. Medical history of the patient included diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, after 9 days of vaccination, the patient developed rashes and itchiness on arm where vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events. The clinical outcome of the events rashes and itchiness on arm were unknown at the time of this report. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added, Narrative "This is a spontaneous report from a contactable consumer" updated to "This is a spontaneous report from a non-contactable consumer"; Final sentence updated to " No follow-up attempts are possible. No further information is expected".

Other Meds:

Current Illness:

ID: 1507999
Sex: M
Age:
State: OH

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Dizziness; Sweating; Shortness of breath; Nausea; Panic attack; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, in left arm on 30Mar2021 15:00 (Lot Number: ER8734), at the age of 27 years, as single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. Patient did not receive any other medications in two weeks. On 30Mar2021 15:00, the patient experienced dizziness, sweating, shortness of breath, nausea and panic attack. The events were considered as non-serious. The events were not received treatment. The outcome of all the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508000
Sex: F
Age:
State: WI

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: upper abdominal swelling after getting the first dose; mottling on abdomen after getting the first dose; abdomen was kind of lumpy after getting the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 1, via an intramuscular route, administered in Arm Left on 03Mar2021 (61-years- at the time of vaccination), as dose 1, single for covid-19 immunization. Medical history included Type 2 Diabetes from 2018 and ongoing. Concomitant medication included valsartan taken for high blood pressure from 2018 and ongoing; hydrochlorothiazide taken for Blood pressure high from 2017 and ongoing; aspirin [acetylsalicylic acid] taken for prophylaxis from 2015 and ongoing; vitamin d nos taken for Vitamin D low from 2016 and ongoing; calcium carbonate taken for absorption of Vitamin D from 2019 and ongoing. On 04Mar2021, the patient experienced, upper abdominal swelling after getting the first dose, mottling on abdomen after getting the first dose and abdomen was kind of lumpy after getting the first dose. Outcome of the event abdomen was kind of lumpy after getting the first dose was unknown, other events was recovered on 08Mar2021. Additional Context: Caller received the second dose of the Covid-19 vaccine. She is reporting that she experienced side effects. She received the second dose on 23Mar2021. Caller is a Pfizer employee reporting on herself. Caller states she had a lot of the common ones other people have reported. She experienced foggy feeling, was flushed, jaw ache, headache, sore neck, eye pain, low grade fever, chills, muscle aches and fatigue. She started feeling foggy 15 minutes later after getting the vaccine. She received the first dose on 03Mar2021. Lot: EL3248. NDC is not provided. The card doesn't indicate the expiry but there is a date of Apr2021 on the card. Caller assumes this is the expiry. It was given intramuscular in the left arm. She adds that after the first dose she had upper abdominal swelling. This lasted for 4 days. She saw her doctor for this. Her abdomen was also mottled and kind of lumpy for lack of a better word. No follow-up attempts are possible. No further information is expected.

Other Meds: VALSARTAN; HYDROCHLOROTHIAZIDE; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D NOS; CALCIUM CARBONATE

Current Illness: Type 2 diabetes mellitus (Verbatim: Type 2 Diabetes)

ID: 1508001
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: muscle around elbow is tender and painful.; difficult to straighten; This is a spontaneous report from a contactable nurse. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Batch/Lot Number: unknown), via an unspecified route of administration on an unknown date in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown that the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient muscle around the elbow was tender, painful and difficult to straighten (muscle stiffness). It was unknown that the patient received any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained Amendment: This follow-up report is being submitted to amend previously reported information: Patient's country, vaccination facility country, best doctor or health care professional information were added and event onset date for AE "Difficult to straighten" was added in events tab.

Other Meds:

Current Illness:

ID: 1508002
Sex: M
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Diarrhea; Fever of roughly 38.5C; Mild tiredness; Loss of appetite; Mild injections site tenderness; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administrated on 26Mar2021 at 17:45 (at the age of 20-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to unknown date. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 27March2021 at 15:00 the patient experienced Fever of roughly 38.5C, mild tiredness, loss of appetite and mild injections site tenderness and at 15:45 after 22 hours of the first dose of vaccine, the patient experienced diarrhea. All foods consumed within the timeframe were unassociated with incidents of diarrhea in the past, though not frequently consumed. These included rye and mushroom soup, neither of which are associated with allergies or intolerances. The patient stated that this was not to say that there was a definitive connection with the first dose of the vaccine, but a correlation was present. The patient did not received any treatment for the reported events. The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C. The clinical outcome of the events diarrhea, fever, mild tiredness, loss of appetite and mild injections site tenderness were recovering. No follow-up attempts are needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: The date for Lab data captured as: 27Mar2021, Narrative 'The patient underwent lab tests or procedure, which include body temperature on an unknown date and tested with a temperature of 38.5C' update as 'The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C' and Dose description was updated in narrative.

Other Meds:

Current Illness:

ID: 1508003
Sex: F
Age:
State: PA

Vax Date: 03/25/2021
Onset Date: 03/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Left arm soreness.; Red mark about the size of a dime around the injection site.; the injection site had a bit of a burning or stinging sensation; my arm was just sore; Menstrual spotting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A 40-years-old female (Non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included intermenstrual bleeding from an unknown date and unknown if ongoing patient have a recent history of spotting. No Allergies to medications, food, or other products. Concomitant medication included oxymetazoline hydrochloride (CLARITIN ALLERGIC); triamcinolone acetonide (NASACORT); desogestrel, ethinylestradiol (VELIVET); ascorbic acid, betacarotene, biotin, calcium phosphate dibasic, calcium stearate, chromic chloride hexahydrate, copper sulfate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, panax ginseng, pantothenic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenate, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc oxide (CENTRUM ACTIVE); calcium carbonate, colecalciferol (VITAMIN D 2000) all are taken for an unspecified indication, start and stop date were not reported patient received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No covid test post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination Patient did not been tested for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2 (Lot number: EN6203) on 03Mar2021for COVID-19 immunization. On 25Mar2021 10:30 patient experienced Left arm soreness. Red mark about the size of a dime around the injection. May be a half hour after the injection, the injection site had a bit of a burning or stinging sensation but that lasted a version short time. Then later in the afternoon patient arm was just sore. It was reported that the date when patient first became aware of adverse event was 25Mar2021. It was reported that On Mar2021 patient experience Menstrual spotting, starting sometime the day after or days after his second dose (I'm not sure of the exact timing in relation to my vaccination). It was reported that patient had recent history of spotting so didn't think much of it. However, the spotting has been consistent since then and grown increasingly heavier. It was reported that patient read an article today that heaver menstrual cycles or spotting may be a side effect of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Reporter considered all event was not serious. Patient did not receive any tenement for the events. The outcome of event menstrual spotting was not recovered, and outcome of all other events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: CLARITIN ALLERGIC; NASACORT; VELIVET; CENTRUM ACTIVE; VITAMIN D 2000

Current Illness:

ID: 1508004
Sex: M
Age:
State: FL

Vax Date: 03/29/2021
Onset Date: 03/30/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Body aches (across entire body); Chills; Sore arm where injected; Lethargy/ need to sleep; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on 29Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. It is unknown, if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient got tested for COVID-19. On 30Mar2021 at 06:00, the patient experienced body aches (across entire body), chills, sore arm where injected and lethargy/ need to sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of body aches, chills, sore arm and lethargy. The clinical outcome of the events body aches, chills, sore arm where injected and lethargy was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/ batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: reporter reported for brother, patient name removed from reporter tab, and reporter address detail removed from patient tab.

Other Meds:

Current Illness:

ID: 1508005
Sex: M
Age:
State:

Vax Date: 03/20/2021
Onset Date: 03/27/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Rash on legs and arms mainly; Noticed some spots on arms; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 20Mar2021 at 13:30 (at the age of 47-year-old), as dose 1, single in left arm for COVID-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications received within 2 weeks of vaccination included bupropion hydrochloride (WELLBUTRIN); vilazodone hydrochloride (VIIBRYD); and amfetamine aspartate, amfetamine sulfate, dexamefetamine saccharate and dexamefetamine sulfate (ADDERALL); taken for unspecified indications, start and stop dates were not reported. It was reported that the patient was getting COVID test if possible. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, 6 days, 10 hours and 30 minutes after the administration of first dose of vaccine, the patient experienced rash on legs and arms and mainly noticed some spots on arms (spot-like rash) in the evening and really spread on Tuesday and today (day of the report). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination and unknown whether the patient was tested COVID post vaccination. The clinical outcome of the event rash on legs and arms and spots on arms was not resolved at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: "Relevant Med History: None" removed since not clearly reported this in source.

Other Meds: WELLBUTRIN; VIIBRYD; ADDERALL

Current Illness:

ID: 1508006
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: fatigue; nausea; This is a spontaneous report from a non-contactable consumer. A 74-years-old male patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown whether the patient has received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. It was unknown since the vaccination, if the patient had COVID-19 test. On an unknown patient experienced fatigue and some nausea for 2 days and was back to normal. It was unknown whether the patient received any treatment for the adverse events. The clinical outcome of the events was recovered on unspecified date (reported as back to normal). No follow-up attempts are possible; information about lot number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Primary reporter name was added. VAERS Primary reporter Addl Qualification updated as patient per source. Patient's first name updated. The outcome of events was updated as recovered per source.

Other Meds:

Current Illness:

ID: 1508007
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Breakthrough bleeding while on birth control; Daughter also had swollen lymph nodes, under her arm; Exposure to Sars-CoV-2 at work; This is a spontaneous report from a contactable consumer (patient mother). A female patient of an age 27 (unspecified age units) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient concomitant medications included unspecified birth control pills; start date and stop date were not reported. This report was not related to a study or programme. Reason for no lot number of Covid-19 vaccine was stated as Caller unwilling to complete the report. The patient experienced breakthrough bleeding while on birth control, also had swollen lymph nodes, under her arm, exposure to sars-cov-2 at work on an unspecified date. Caller reported that patient received the Pfizer-Biontech Covid19 vaccine. Then, 2 weeks afterward, she had breakthrough bleeding, even though she was taking birth control pills. Daughter also had swollen lymph nodes, under her arm. In response, reporter was informed that no information was available from the clinical trials regarding effects on menstruation. Lymphadenopathy was a commonly reported AE. Caller reports that patient was a pharmacist and fully vaccinated with the Pfizer-Biontech Covid19 vaccine, recently had an exposure to Sars-CoV-2 at work. All the technicians that she worked with got Sars-CoV-2, and since she was vaccinated, she did not get it. Caller stated that was good news, it must work. In response, provided efficacy data from the fact sheet. Caller stated that patient had both doses of the Covid-19 vaccine. And was on birth control and experienced breakthrough bleeding, swollen lymph nodes. When caller was asked if she would be willing to complete a safety report on the patient, the caller replied that it was up to the patient to report her experience. Caller reported that the patient was a pharmacist, and she did not want to impede on her privacy. Caller reported that the patient went to the doctor for the lymph node thing and the patient's physician instructed the patient to just put a warm compress on her lymph nodes and that the swelling was just from irritation. Caller reported that her physician when told of the patients swollen lymph nodes said, "no we are seeing that". The events were reported as not serious. Clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508008
Sex: F
Age:
State:

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Woke up with strong shivers, hard jawquivering; 103 degree fever; extreme muscle fatigue; Slept a full day; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non pregnant female patient received the unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, lot no: unknown) via unspecified route of administration on 27Mar2021 at 14:30 (at the age of 23-years-old) as a Dose number Unknown, Single for COVID-19 immunization. The medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, at 03:00, the patient had woken up with strong shivers, hard jaw quivering, 103-degree fever, extreme muscle fatigue and had slept a full day. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The patient underwent lab tests and procedures that included Body temperature of 103 degree. The clinical outcome of the events shivers, hard jaw quivering, fever, muscle fatigue and sleepy were recovered/resolved on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added; 2. 103 degree fever added as lab data.

Other Meds:

Current Illness:

ID: 1508009
Sex: F
Age:
State: NY

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Caller states the next day she had tiny swelling at the injection site.; has a 2.5 inch circle around injection site.; little pain at the injection site; redness that has gotten bigger; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX US SUPPORT. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 19Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 20Mar2021, the next day after vaccination she had tiny swelling at the injection site. Caller states yesterday the area was not swollen or raised. Caller states today it is flat and has a 2.5-inch circle around injection site. On an unspecified date, she had a little pain at the injection site that has went away. Had a raised mark; redness that has gotten bigger and not gone away after two weeks now. Caller would like to know if this is normal or something she should be concerned about or report. Caller would like to know if she should send or upload picture. Is scheduled for her second shot next Friday. Outcome of the event vaccination site pain was recovered, vaccination site swelling, and vaccination site erythema was not recovered, vaccination injury was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained

Other Meds:

Current Illness:

ID: 1508010
Sex: F
Age:
State: OH

Vax Date: 03/23/2021
Onset Date: 03/25/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: it constricted her breathing/couldn't breath; Costochondritis/there was inflammation her ribs; bruising; has been having on and off rashes on her chest; waking up in the middle of the night; had a flare up and it got really red and itchy; had a flare up and it got really red and itchy/Then Randomly her Ear is on fire, its bright red; sore arm/arm soreness; punch inflammation inflammatory reaction; Redness in chest; Swollen lymph nodes; ear on fire and is bright red; bad chest pain; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 07:00 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included prednisone (PREDNISONE) 10mg, 3 times a day for first 2 days; 2 10mg tablets for twice a day for next 2 days. States that after doctor stopped the Prednisone, she was put on Cyclobenzaprine and Hydroxyzine. States that she was just given these today. On an unspecified date, the patient experienced sore arm/arm soreness, punch inflammation inflammatory reaction, redness in chest, swollen lymph nodes, it constricted her breathing/couldn't breath, costochondritis/there was inflammation her ribs, bruising, has been having on and off rashes on her chest, waking up in the middle of the night, had a flare up and it got really red and itchy, had a flare up and it got really red and itchy/then randomly her ear is on fire, its bright red, her ear is on fire, its bright red on 01Apr2021 and bad chest pain on 25Mar2021. Sore arm, Thursday punch inflammation inflammatory reaction. Redness in chest. Swollen lymph nodes. Twice to HCP, tried prednisone. Asking for recommendation on second dose. Potential duplicate AE. States she has been having some really weird side effects. States that it has been 9 days since the first shot. States that in the first couple of days, she just had arm soreness. On the third day, started having really bad chest pain, almost like someone was punching her in the chest. States that it constricted her breathing. Went to the ER and they said she had Costochondritis, stating there was inflammation her ribs. States that under her arm is really hurting and there is bruising under her sternum. States that she has been having on and off rashes on her chest. States that she went to her primary doctor twice, including today. States that her doctor told her to call Pfizer to see if she should be getting the second dose of the vaccine, or if she should get the Moderna vaccine. States that her doctor stated it may have been an allergic reaction to the vaccine. Chest pain and arm pain: States that she got the shot on 23Mar2021 and the chest pain started on 25Mar2021. States that it started up on top of the front of the arm and down around the arm. Was more severe in the side that she got the vaccine. States that the other arm is hurting a bit, but mostly in the same arm. States that it is still hurting now. Treatment was given Ibuprofen in the ER and was given a prescription for 800mg Ibuprofen prescription. States that she went to the doctor on Monday and was given Prednisone. States that she went again today because of more things happening, she was waking up in the middle of the night, her chest was pounding and she couldn't breath and that went away but then she would get rashes and that would go away. States that she has always had these since this happened. States that there is redness on her chest, mostly from inflammation. A few days ago, had a flare up and it got really red and itchy. States that it goes away in an hour. States that this occurs randomly. Then Randomly her Ear is on fire, its bright red and then goes away for an hour. States that this started today. She is not sure if this is from the Prednisone because it occurred shortly after taking it. The patient underwent lab tests and procedures which included chest x-ray: normal, electrocardiogram: normal. Therapeutic measures were taken as a result of sore arm/arm soreness, punch inflammation inflammatory reaction, bad chest pain. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: PREDNISONE

Current Illness:

ID: 1508011
Sex: F
Age:
State:

Vax Date: 03/28/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: cough; slight difficulty breathing; This is a spontaneous report received from a contactable consumer (Patient). This 46-Year old (age at vaccination) female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. Patient's medical history included seasonal pollen allergy. Concomitant medications were not reported. A 46-year-old patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 28Mar2021, in the last 2 days she has experienced a cough and slight difficulty breathing, she asks if these are symptoms associated with the vaccine COVID-19, or if they may have been caused by her seasonal pollen allergy. A review of the EUA PI (LAB-1457-6.0, revised Feb2021) did not find information about cough and difficulty breathing (several days after vaccination) associated with the Pfizer-BioNTech COVID-19 vaccine. Per PI/Contraindications (LAB-1457-6.0, revised Feb2021), those symptoms are not listed as contraindications to the 2nd dose, but was referred to an HCP for individualized guidance, suggested to mention all her symptoms, medical conditions and relevant clinical history. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508012
Sex: F
Age:
State:

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Itchy arms,; Red and small bumps; Headache; Body aches; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 26-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 at 13:00 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had a history of allergy to lamb, dairy, corn and potatoes. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the COVID-19 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 30Mar2021 at 21:00, the patient experienced Itchy arms, red and small bumps, headache and body aches. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of Itchy arms, red and small bumps, headache and body aches were resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Treatment Received selected as No for Headache.

Other Meds:

Current Illness:

ID: 1508013
Sex: F
Age:
State: NY

Vax Date: 01/26/2021
Onset Date: 02/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: numbness in both legs and right arm; pain in back; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 67-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; El898Z), via an unspecified route of administration in arm left on 26Jan2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included the patient was diagnosed with COVID-19 prior to vaccination and had no known allergies to medications, food, or other products. The concomitant medication included levothyroxine sodium (SYNTHROID) 50 mg for an unknown indication. On 18Jan2021, the patient underwent throat swab, and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After one week of the vaccination, on 02Feb2021 at 15:45, patient experienced numbness in both legs and right arm and pain in back. The patient did not receive any treatment for the adverse event. The clinical outcome of the event numbness in both legs and right arm and pain in back were not resolved at the time of report. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: adverse event (AE) onset latency was recalculated. For lab test "Throat swab" was re-coded as "SARS-CoV-2 test". For con-med, "50 mg" was added as dose/units". Lead sentence update as "...a contactable consumer". Final sentence updated as "No follow-up attempts are possible. No further information is expected."

Other Meds: SYNTHROID

Current Illness:

ID: 1508014
Sex: F
Age:
State: CA

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Explosive diarrhea; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00 the patient experienced nausea. On 01Apr2021 at 23:45, the patient experienced explosive diarrhea which was 36 hours after vaccine. The patient did not receive any treatment for reported adverse events. The clinical outcome of the event nausea and explosive diarrhea were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1508015
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 03/30/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Arm soreness,; Weakness throughout entire body; Lethargy; Fever; Migraine; Sweating,; Cold shivers; Upset stomach; Diarrhoea; This is a spontaneous report from a contactable nurse, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis, acne and sciatica. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), tretinoin (RETIN A), probiotics (MANUFACTURER UNKNOWN) fenugreek capsules (MANUFACTURER UNKNOWN) and pre workout drinks (MANUFACTURER UNKNOWN) all taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 04Dec2020 and 11Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 at 07:00, the patient experienced arm soreness, weakness throughout entire body, lethargy, fever, migraine, sweating, cold shivers, upset stomach and diarrhea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included intake of ibuprofen (MANUFACTURER UNKNOWN) for the events arm soreness, fever, migraine and cold shivers. The clinical outcome of the events arm soreness, weakness throughout entire body, lethargy fever, migraine, sweating, cold shivers, upset stomach and diarrhea were resolved on an unspecified date in 2021. No follow-up attempts are needed; information about lot number cannot be obtained.

Other Meds: SPIRONOLACTONE; RETIN A

Current Illness:

ID: 1508016
Sex: F
Age:
State: AZ

Vax Date: 03/31/2021
Onset Date: 04/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; arm is swollen; feels hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 08:00, the patient's left eye was swollen and painful and watery. The patient's arm was swollen and felt hot to touch. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events left eye swollen and painful and watery, arm was swollen and felt hot to the touch were not recovered. No follow-up attempts are needed; information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508017
Sex: F
Age:
State: NM

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: A little tired; Started menstruating 14 days before; High flow early in the period; Exhausted; Fever; Unusual back ache; Hips really hurt; Quadriceps really hurt; Mild pain around inject site; Normal recovering bruise; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0510), via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included a basal metabolic index of 30.0, normal blood pressure, cholesterol and pulse. The patient also reported that she was previously anaemic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced seasonal pollen allergies and had no other allergies. Concomitant medications included a generic brand multivitamin (MANUFACTURER UNKNOWN) two times per day, iron (IRON) (ir supplement) both taken from an unknown date for unknown indications, and paragard (INTRAUTERINE DEVICE) since just over four years. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207), via an unspecified route of administration in the left arm on 09Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 16:30, the patient experienced an unusual back ache, hips and quadriceps that really hurt, very mild pain around inject site, a normal recovering bruise. On 01Apr2021 at 20:00, the patient reported that she was exhausted and developed a fever that was more than 4-degree Fahrenheit above her normal body temperature. The patient reported that she slept for 12 hours. On 02Apr2021, the patient was a little tired but reported that the aches and fever had subsided. On 02Apr2021, the patient suddenly started menstruating that afternoon, about 14 days before the expected start (started early) and had a high flow early in the period. The patient reported that since she was on the IUD from just over 4 years, she had 26-31 days between her cycles and the early period and high flow caught her off guard. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included intake of NSAIDS (unspecified) for back ache, hips and quadriceps that really hurt, pain around inject site and fever. The patient did not receive any treatment for the events inject site bruise, exhausted, irregular period, heavy flow and felt tired. The clinical outcome of the events unusual back ache, hips really hurt, quadriceps really hurt, pain around inject site, inject site bruise, exhausted, fever, felt tired, menstruating 14 days before and high flow early in the period were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: IRON; PARAGARD

Current Illness:

ID: 1508018
Sex: F
Age:
State: UT

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: dizziness; vertigo or feeling of spinning; Extreme headache; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (GNC) for an unknown indication and from an unknown date. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 10Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 23:00 (also reported one day after), the patient had experienced extreme headache and nausea. On 02Apr2021 (reported as began on third day of vaccination), she had dizziness/vertigo or feeling of spinning. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events nausea, vertigo or feeling of spinning, extreme headache and dizziness were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508019
Sex: F
Age:
State: MI

Vax Date: 03/29/2021
Onset Date: 04/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Severe pain in lymph node(s) under left arm, in arm pit; Severe swelling and pain in lymph node(s) under left arm, in arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK6213) via an unspecified route of administration in the left arm on 29Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unknown date and allergy to sulfa's. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 07:00, the patient experienced severe swelling and pain in lymph node(s) under left arm, in arm pit. The patient received shot on Monday and had absolutely no reaction, not even a sore arm, until she woke up on Friday morning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe swelling and pain in lymph node(s) under left arm, in arm pit and included application of heat and massage (as tolerable). The clinical outcome of the events severe swelling and pain in lymph node(s) under left arm, in arm pit was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1508020
Sex: F
Age:
State: OH

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: tired and spacey; Chills; felt light headed; thirsty; headache; back ache; fever; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) , calcium carbonate (CALTRATE), ascorbic acid, tocopheryl acetate, zinc oxide, cupric oxide, betacarotene (PRESERVISION) and diphenhydramine hydrochloride (BENADRYL) from started on unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 01:00, the patient experienced chills, started in the middle of the night, felt light headed and really thirsty when she got up. Then at about noon on 27Mar2021, she had a really bad headache, back ache, fever nausea and vomiting that lasted until morning. The next day on 28Mar2021, the patient, was tired and spacey. On third day the patient felt more like herself, but tired. On fourth day she felt great and back to happy normal self. The patient did not receive any treatment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, back ache, fever, nausea, vomiting, chills, felt light headed, thirsty and tired was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: TRAZODONE; Caltrate; PRESERVISION; BENADRYL; D3 VITAMIN

Current Illness:

ID: 1508021
Sex: F
Age:
State: CO

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Developed rash starting day after and continued to 2nd day. Rash is up and down arms and legs and on back; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included knee surgery. The patient had no known allergies. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) twice daily, received after knee surgery. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 (day after vaccine), the patient experienced rash which continued to second day (03Apr2021). It was stated that the rash was up and down arms and legs and on back. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event rash was not recovered at the time of this report. No follow-up attempts are needed; information about lot or batch number cannot be obtained.

Other Meds: Aspirin

Current Illness:

ID: 1508022
Sex: M
Age:
State: GA

Vax Date: 03/28/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: COVID symptoms developed 4 days later; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included sciatica. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) 800mg from an unknown date for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021 at 15:00, 4 days after the vaccination, the patient experienced COVID symptoms and was tested positive for COVID five days later. The patient did not receive any treatment for the reported event. On 02Apr2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and the result was positive. The clinical outcome of the event COVID symptoms developed 4 days later was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1508023
Sex: F
Age:
State: WI

Vax Date: 03/26/2021
Onset Date: 04/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact injection site; Soreness in lymph nodes at arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 23:00 the patient experienced soreness and swelling at injection site (7 days after the first injection), red spot at exact injection site and soreness in lymph nodes at arm pit. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events soreness and swelling at injection site, red spot at exact injection site and soreness in lymph nodes at arm pit were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508024
Sex: F
Age:
State: AZ

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Worsening SOB; cough; This is a spontaneous report from a contactable healthcare professional via COVID-19 Adverse Event Self-Reporting Solution . A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration on 22Mar2021 as a single dose for COVID-19 immunization. Medical history included psoriatic arthritis and asthma from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASA), taken for an unspecified indication, start and stop date were not reported; secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported; gabapentin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; lysine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; meloxicam (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; nicotinic acid (NIACIN) taken for an unspecified indication, start and stop date were not reported; cyproheptadine hydrochloride (PERIACTIN) taken for an unspecified indication, start and stop date were not reported; calcium, magnesium (MANUFACTURER UNKNOWN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took lidocaine and experienced drug allergy. The patient experienced worsening shortness of breath (SOB) and cough on 23Mar2021 with outcome of unknown. Details were as follows: On 23Mar2021, the patient experienced worsening SOB and cough. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of worsening SOB and cough was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ASA; COSENTYX; GABAPENTIN; LYSINE; MELOXICAM; NIACIN; PERIACTIN; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]

Current Illness:

ID: 1508025
Sex: M
Age:
State: AL

Vax Date: 04/02/2021
Onset Date: 04/03/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 03:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis (reported as sinus) and reflux. The patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), pantoprazole sodium sesquihydrate (PROTONIX) and loratadine (CLARITIN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 10:00 the patient experienced low grade fever 100.2 (units unspecified) and chills also sore arm at injection site. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever 100.2 and chills also sore arm at injection site was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: Claritin; Protonix; EFFEXOR

Current Illness:

ID: 1508026
Sex: F
Age:
State: TN

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: tingling in tongue; nausea; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included retinol (VITAMIN A), cetirizine hydrochloride (ZYRTEC) and paracetamol (TYLENOL) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 16:00 the patient experienced soreness at injection site(vaccination site pain). On 02Apr2021 the patient experienced nausea and body aches(general body pain). On 03Apr2021 the patient experienced tingling in tongue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event soreness at injection site, nausea, body aches and tingling in tongue was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: Vitamin a; Zyrtec; TYLENOL

Current Illness:

ID: 1508027
Sex: M
Age:
State: MD

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: I had giant sublingual glands; I noticed because one of my backteeth hurt and I looked in the mirror.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on an unknown date in Apr2021, (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 the patient experienced giant sublingual glands under the lower jaw of teeth and tongue and back teeth hurt (tooth ache). It was reported that within about 8 hours of getting the first dose the patient noticed about giant sublingual glands under his lower jaw teeth and tongue because one of his back teeth was hurt, when he looked in the mirror. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events giant sublingual glands and toothache (back teeth hurt) were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SERTRALINE

Current Illness:

ID: 1508028
Sex: F
Age:
State: CT

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Fever; chills; stomach upset; tired; This is a spontaneous report from a contactable consumer. An adult female patient (unknown if pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. It was unknown if any other vaccines received within four weeks prior to the COVID-vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. On 28Mar2021, the patient experienced fever and chills 2 days, stomach upset next 24 hours, tired for additional days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any treatment for the reported events. The clinical outcome of fever and chills was recovered on 30Mar2021, stomach upset was recovered on 29Mar2021 and tiredness was recovered in 2021. This report was reported as non-serious by reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm